Lipoic Acid for Progressive Multiple Sclerosis (MS)

NCT03161028 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: B2682-R
• Study Type: interventional
• Target: 115
• Locations: 2 countries
• Sites: 11

Brief Summary

The purpose of the study is to determine if lipoic acid can preserve mobility and protect the brain in progressive forms of multiple sclerosis.

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis; magnetic resonance imaging; gait; neuroprotective agents; thioctic acid; alpha-lipoic acid; mobility; chronic progressive multiple sclerosis

Outcome Measures

Primary Outcomes (1)

• Change in Mobility: Timed 25 Foot Walk

  T25FW was transformed to walking speed by dividing 25 feet by the completion time in seconds (ft/sec). The change in walking speed across 24 months was compared between treatment groups using a mixed models analysis.

  24 months

Secondary Outcomes (3)

• Change in Mobility: 2-minute Timed Walk

  24 months

• Mobility: Fall Count

  24 months

• Brain Atrophy by MRI

  24 months

Other Outcomes (1)

• Safety: Adverse Event Monitoring

  24 months

Study Arms (2)

Arm 1: Lipoic Acid

EXPERIMENTAL

59 subjects receive oral lipoic acid 1200mg daily

Drug: Lipoic acid

Arm 2: Placebo

PLACEBO COMPARATOR

59 subjects receive placebo daily

Drug: Placebo

Interventions

Lipoic acid DRUG

1200 mg taken by mouth daily for two years starting on day one of the study and ending on the last day of study participation.

Also known as: Alpha-lipoic acid

Arm 1: Lipoic Acid

Placebo DRUG

The placebo comparator will be taken by mouth daily for two years starting on day one of the study and ending on the last day of study participation

Arm 2: Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of progressive MS as defined by the study
• Able to give informed consent and to adhere to study procedures.
• Expanded Disability Status Scale (EDSS) 3.0 - 6.5: ambulatory for at least 20 meters without rest and use of bilateral aids (canes, crutches, walker) or better.

You may not qualify if:

• A self-reported medical or neurological problem other than MS that is a cause of progressive or fluctuating gait dysfunction
• Unable to undergo MRI
• Unable to follow directions in English as standardized scales are not all validated in other languages.
• Current major disease or disorder other than MS (e.g., cancer, renal disease, end-stage cardiopulmonary disease, post-traumatic stress disorder, etc.) that may interfere with study procedures. Note: Stable abnormal laboratory values of no more than Grade 1 determined to not be of clinical significance to the primary treating physician for that condition may be permitted per local site investigator discretion.
• Pregnant or breast-feeding.
• Insulin-dependent diabetes or diabetes not controlled on oral diabetes medications.
• Scheduled (every 3 months or more frequently) IV or oral steroids in the year prior to enrolment.
• IV or oral steroids in the 60 days prior to enrolment.
• Use of LA in the prior 2 years exceeding the equivalent of 1200mg daily for 3 months.
• Participation in the pilot LA in SPMS trial.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (11)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

Washington DC VA Medical Center, Washington, DC

Washington D.C., District of Columbia, 20422, United States

Location

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97207-2964, United States

Location

VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Dallas, Texas, 75216, United States

Location

University of Utah

Salt Lake City, Utah, 84148, United States

Location

VA Salt Lake City Health Care System, Salt Lake City, UT

Salt Lake City, Utah, 84148, United States

Location

University of Vermont

Burlington, Vermont, 05401, United States

Location

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, 98108, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

Ottawa Hospital Research Institute

Ottawa, Ontario, K1Y 4E9, Canada

Location

Related Publications (2)

• Spain RI, Paz Soldan MM, Freedman MS, Repovic P, Solomon AJ, Rinker JR, Wallin MT, Haselkorn JK, Stuve O, Gross RH, Waslo CS, Hildebrand A, Morris CD, Mitchell J, Turner AP, Schwartz DL, Metz J, Rooney W. Lipoic Acid for Treatment of Progressive Multiple Sclerosis: A Phase 2 Randomized Clinical Trial. Neurology. 2026 Jan 13;106(1):e214454. doi: 10.1212/WNL.0000000000214454. Epub 2025 Dec 15.

  PMID: 41397213 DERIVED

• Spain RI, Hildebrand A, Waslo CS, Rooney WD, Emmons J, Schwartz DL, Freedman MS, Paz Soldan MM, Repovic P, Solomon AJ, Rinker J 2nd, Wallin M, Haselkorn JK, Stuve O, Gross RH, Turner AP. Processing speed and memory test performance are associated with different brain region volumes in Veterans and others with progressive multiple sclerosis. Front Neurol. 2023 Jun 8;14:1188124. doi: 10.3389/fneur.2023.1188124. eCollection 2023.

  PMID: 37360346 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive

Interventions

Thioctic Acid

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Carboxylic Acids; Organic Chemicals; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids

Limitations and Caveats

Limitations of the study include issues of low power, COVID-19 pandemic interruptions in study recruitment and data collection, and unexpected study withdrawals due to proteinuria.

Results Point of Contact

• Title: Dr. Rebecca Spain
• Organization: VA Portland Medical Center

rebecca.spain@va.gov

503-346-0768

Study Officials

• Rebecca I. Spain, MD MSPH

  VA Portland Health Care System, Portland, OR

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2017
• First Posted: May 19, 2017
• Study Start: August 17, 2018
• Primary Completion: December 31, 2023
• Study Completion: June 30, 2024
• Last Updated: March 3, 2025
• Results First Posted: March 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (10); CA (1)